Status:
UNKNOWN
The International Collaborative Exfoliation Syndrome Treatment Study
Lead Sponsor:
The New York Eye & Ear Infirmary
Collaborating Sponsors:
Pfizer
Conditions:
Exfoliation Syndrome
Glaucoma
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Purpose: To determine the efficacy of treatment with latanoprost in combination with pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in eyes with XFS and eleva...
Detailed Description
Purpose: To compare the effect of treatment with latanoprost plus pilocarpine vs timolol or fixed combination timolol/dorzolamide (T/D) in eyes with exfoliation syndrome (XFS) and elevated IOP. Metho...
Eligibility Criteria
Inclusion
- Exfoliation syndrome in one or both eyes. Exfoliation material must be present on the anterior lens surface for diagnosis.
- Untreated IOP greater than or equal to 22 mmHg in one or both eyes with or without mild to moderate glaucomatous damage and who, in the judgment of the investigator, can be safely washed off from current medical therapy.
- Age 50-80 years
- Open angles by gonioscopy
Exclusion
- Age over 80 years
- Best corrected visual acuity less than 20/30
- Untreated IOP greater than 35 mmHg
- Currently taking systemic beta-blockers
- Glaucomatous damage sufficiently severe to prevent washout in the opinion of the examiner or visual field defect within 10 degrees of fixation
- Glaucoma other than exfoliation syndrome
- Absence of exfoliation material on the lens surface in the eye to be treated
- Known allergy or sensitivity to any of the study medications
- Ocular pathology that may interfere with the ability to obtain tonography, visual fields, or accurate IOP readings
- Angle-closure glaucoma
- Diabetic retinopathy
- Previous intraocular or laser surgery.
- Unwilling or unable to give consent
- Pregnant or lactating women
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00804115
Start Date
August 1 2000
End Date
December 1 2008
Last Update
December 8 2008
Active Locations (1)
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1
New York Eye and Ear Infirmary
New York, New York, United States, 10003